A Novel Low-Cost Tool for a More Efficient and Reliable Weight-for-Height/Length Assessment

NCT03780348 | Unknown

• 1 other identifier: JSI R&T #18-46
• Study Type: interventional
• Target: 510
• Locations: 0 countries
• Sites: N/A

Brief Summary

Weight-for-height/length z-score is one of the indicators used to diagnose acute malnutrition. In the existing method, the assessment involves three steps and takes significant time with a wider room for errors. A new tool is developed to address these drawbacks. A preliminary testing done show encouraging results, but a more robust study is needed. This research will b done with the objective of comparing diagnostic efficiency and reliability of the 'new' method against the 'existing' one using a diagnostic randomized clinical trial method.

Conditions

Severe Acute Malnutrition; Wasting

Keywords

Weigh-for-Height/Length; Assessment

Outcome Measures

Primary Outcomes (3)

• Diagnostic Reliability

  Proportion of 'assessment errors' between the groups will be compared against that of the gold standard (i.e the assessment done by two experts for each child'

  In 3 months

• Efficiency of assessment

  The average time needed to complete WHZ assessments using the 'new' method will be compared with that of the 'existing' method

  in 3 months

• Reliability of WHZ assessments done by community Health Extension Workers

  Proportion of 'assessment errors' by health-extension workers will be compared with that of the 'nurses' and the 'experts'

  in 3 months

Study Arms (3)

New Method

EXPERIMENTAL

'New' weight-for-height method will be used to assess children assigned to this arm

Diagnostic Test: New Method

Existing Method

ACTIVE COMPARATOR

'Existing' weight-for-height method will be used to assess children assigned to this arm

Diagnostic Test: Existing Method

Health Extension Workers

EXPERIMENTAL

Health Extension workers will do weight-for-height assessment using the new method

Diagnostic Test: New Method

Interventions

New Method DIAGNOSTIC_TEST

A 'new' WHZ tool will be used to assess children.

Health Extension Workers; New Method

Existing Method DIAGNOSTIC_TEST

'Existing' WHZ tools will be used to assess children

Existing Method

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children under five years of age living in the study area.

You may not qualify if:

• Children for whom weigh-for-height assessments can not be done due to physical deformities and disabilities.

Sponsors & Collaborators

• JSI Research & Training Institute, Inc.: lead

Related Publications (4)

• Grellety E, Golden MH. Severely malnourished children with a low weight-for-height have a higher mortality than those with a low mid-upper-arm-circumference: I. Empirical data demonstrates Simpson's paradox. Nutr J. 2018 Sep 15;17(1):79. doi: 10.1186/s12937-018-0384-4.

  PMID: 30217205 BACKGROUND

• Grellety E, Golden MH. Severely malnourished children with a low weight-for-height have a higher mortality than those with a low mid-upper-arm-circumference: III. Effect of case-load on malnutrition related mortality- policy implications. Nutr J. 2018 Sep 15;17(1):81. doi: 10.1186/s12937-018-0382-6.

  PMID: 30217201 BACKGROUND

• Laillou A, Prak S, de Groot R, Whitney S, Conkle J, Horton L, Un SO, Dijkhuizen MA, Wieringa FT. Optimal screening of children with acute malnutrition requires a change in current WHO guidelines as MUAC and WHZ identify different patient groups. PLoS One. 2014 Jul 1;9(7):e101159. doi: 10.1371/journal.pone.0101159. eCollection 2014.

  PMID: 24983995 BACKGROUND

• Pelletier D, Haider R, Hajeebhoy N, Mangasaryan N, Mwadime R, Sarkar S. The principles and practices of nutrition advocacy: evidence, experience and the way forward for stunting reduction. Matern Child Nutr. 2013 Sep;9 Suppl 2(Suppl 2):83-100. doi: 10.1111/mcn.12081.

  PMID: 24074320 BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Yared A Fantaye, MD, MPH

  JSI Training and Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yared A Fantaye, MD, MPH

CONTACT

+251 911944651; yared_abebe@et.jsi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The caregivers of the children, the care provider linking the children to either of the groups and the investigator will not know which group each child is joining and which group is using which method.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will be assigned for nutrition status assessment to either of the two groups that use the 'new' or the 'existing' assessment method

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share